In the section Expected Near-Term Clinical Milestones, under Trial Initiations, the fourth bullet should read "Sage-217 in MDD" (instead of "Sage-547"). Under Data Readouts, the third bullet should read "Sage-217 in MDD" (instead of "Sage-547"). The corrected release reads: SAGE THERAPEUTICS ANNOUNCES THIRD QUARTER 2016 FINANCIAL RESULTS AND PROVIDES SRSE EUROPEAN UPDATE Positive Scientific Advice From European Medicines Agency on Development of SAGE-547 in SRSE Provides Regulatory Path in E.U. Ongoing Phase 3 STATUS Trial Expected to be Sufficient to Support a European Marketing Authorization Application for SAGE-547 in SRSE Eight Clinical Trials Across Pipeline Expected to Generate Top-Line Data in 2017 Moving into Next Strategic Phase - a Multi-Product, Neuropsych Development Portfolio Conference Call Today at 8:00 AM ET Sage Therapeutics, Inc. (NASDAQ: SAGE) today reported financial results for the third quarter ended September 30, 2016 and an update on its corporate strategy. Sage recently received positive Scientific Advice from the European Medicines Agency (EMA) on the development of SAGE-547 in the treatment of patients with super-refractory status epilepticus (SRSE). Based on the Scientific Advice from the EMA, Sage believes its current Phase 3 program, if successful, will be sufficient to support a European Marketing Authorization Application (MAA) to the EMA for the SRSE indication. Scientific Advice is a procedure offered by the EMA to stakeholders for clarification of questions arising during development of medicinal products and focuses on development strategies rather than pre-evaluation of data to support an MAA. "The recent EMA Scientific Advice provides Sage with a clear regulatory path forward in SRSE in the E.U. and is important for Sage as we plan for top-line results from the Phase 3 STATUS Trial in SRSE, expected in the first half of next year, while continuing to lay the groundwork for a potential near-term commercial launch of SAGE-547," said Jeff Jonas, M.D., Chief Executive Officer of Sage. "Building on our recent clinical and regulatory accomplishments, including FDA Breakthrough Therapy Designation for SAGE-547 in postpartum depression (PPD), we continue to transform Sage. We are now poised to drive our strategy to the next phase - a multi-product, neuropsych development portfolio across three distinct disease areas: neurology with SRSE, mood disorders with PPD and major depressive disorder (MDD), and movement disorders with essential tremor and Parkinson's. As we continue to explore the potential applications of our novel compounds through deliberate and stepwise development, Sage is now well-positioned to produce eight important data readouts throughout 2017."
Pipeline UpdateSage is advancing a portfolio of multiple, novel central nervous system (CNS) product candidates targeting the GABA A and NMDA receptor systems. Dysfunction in these systems are known to be at the core of numerous psychiatric and neurological disorders. Sage is employing an innovative development approach focused on indications where patient populations are easily identified, clinical endpoints are well-defined, and development pathways are feasible.
- SAGE-547: Sage is currently developing SAGE-547 in separate clinical programs for the treatment of SRSE and PPD:
- SRSE: Sage is enrolling the Phase 3 STATUS Trial, a global, randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 as a treatment for SRSE.
- PPD: Based on positive results from the placebo-controlled 202A clinical trial in severe PPD, Sage expanded its development program evaluating SAGE-547 for PPD with the initiation of two additional multi-center, placebo-controlled trials, one of which is a dose-ranging study of SAGE-547 in severe PPD patients ( 202B) and the other is studying the efficacy of SAGE-547 in moderate PPD patients ( 202C). Both clinical trials are currently enrolling. In September, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to SAGE-547 for the treatment of PPD. Sage is currently in discussions with the FDA regarding the design of the program to support a possible New Drug Application (NDA) approval.
- SAGE-217: Sage plans to focus clinical development of SAGE-217, a novel, orally-active next generation GABA modulator, on both mood and movement disorders, with four Phase 2 clinical programs expected to begin by the end of 2016.
- Mood Disorders:
- PPD: Sage plans to initiate a Phase 2 clinical program for SAGE-217 in PPD based on positive results to date from the SAGE-547 PPD clinical program. The Phase 2a multi-center, double-blind, placebo-controlled, randomized trial will evaluate the efficacy, safety, tolerability, and pharmacokinetics of SAGE-217 in the treatment of patients with PPD.
- MDD: Sage plans to initiate a two-part Phase 2 clinical trial of SAGE-217 in MDD. Part A of the Phase 2 trial will be an open-label, proof-of-concept study which, if positive, may lead to a larger randomized, placebo-controlled Phase 2 trial.
- Movement Disorders:
- Essential tremor: Based on prior positive proof-of-concept data, Sage plans to initiate a Phase 2 clinical program for SAGE-217 in essential tremor. The Phase 2a multi-center, double-blind, placebo-controlled, randomized withdrawal trial will evaluate the efficacy, safety, tolerability, and pharmacokinetics of SAGE-217 in the treatment of patients with essential tremor.
- Parkinson's disease: Sage plans to initiate a two-part Phase 2 clinical trial of SAGE-217 in Parkinson's disease. Part A of the Phase 2 trial will be an open-label, proof-of-concept study which, if positive, may lead to a larger randomized, placebo-controlled Phase 2 trial.
- Other GABA Programs: Sage is currently evaluating a series of novel GABA modulators in pre-clinical development, including SAGE-105, SAGE-324 and SAGE-689. Sage is planning to initiate IND-enabling studies this year for a novel, orally active next generation GABA modulator, either SAGE-105 or SAGE-324, which is intended to be developed for GABA-related indications, such as orphan epilepsies.
- SAGE-718: Sage is also studying novel compounds that target the NMDA receptor. The lead NMDA product candidate is SAGE-718, a novel NMDA positive allosteric modulator, currently being tested in IND-enabling studies. Sage expects to initiate Phase 1 clinical development for SAGE-718 in 2017.
- Mood Disorders:
- Trial Initiations:
- Phase 2 trial of SAGE-217 in essential tremor (Q4 2016)
- Phase 2 trial of SAGE-217 in PPD (Q4 2016)
- Phase 2 proof-of-concept trial of SAGE-217 in Parkinson's disease (Q4 2016)
- Phase 2 proof-of-concept trial of SAGE-217 in MDD (Q4 2016)
- Phase 1 program of first NMDA candidate, SAGE-718 (1H 2017)
- Data Readouts:
- Phase 3 STATUS Trial of SAGE-547 in SRSE (1H 2017)
- Phase 2 proof-of-concept trial of SAGE-217 in Parkinson's disease (1H 2017)
- Phase 2 proof-of-concept trial of SAGE-217 in MDD (1H 2017)
- 202B trial of SAGE-547 in PPD (2H 2017)
- 202C trial of SAGE-547 in PPD (2H 2017)
- Phase 2 trial of SAGE-217 in essential tremor (2H 2017)
- Phase 2 trial of SAGE-217 in PPD (2H 2017)
- Phase 1 SAD trial of SAGE-718 (2H 2017)
- Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2016 were $431.3 million, compared with $186.8 million at December 31, 2015. The increase was primarily due to net proceeds of $189.2 million, after deducting commissions and underwriting discounts, from Sage's follow-on public offering completed in September 2016.
- R&D Expenses: Research and development expenses were $29.1 million, including $2.5 million of non-cash stock-based compensation expense, in the third quarter of 2016, compared to $17.5 million, including $1.5 million of non-cash stock-based compensation expense, for the same period of 2015. The increase in R&D expense was primarily due to the ongoing clinical development of SAGE-547 in SRSE and PPD, completion of Phase 1 development for SAGE-217 and preparation for initiation of the Phase 2 clinical programs, the ongoing IND-enabling studies for SAGE-718 and investments in R&D headcount to support the growth in Sage's pipeline and operations.
- G&A Expenses: General and administrative expenses were $9.0 million, including $2.2 million of non-cash stock-based compensation expense, in the third quarter of 2016, compared to $6.6 million, including $2.9 million of non-cash stock-based compensation expense, for the same period of 2015. The increase in G&A expenses was primarily due to the increase in personnel-related expenses and professional fees to support expanding operations, as well as early commercial planning.
- Net Loss: Net loss was $37.8 million for the third quarter of 2016 compared to net loss of $24.0 million for the same period of 2015.
- Financial Guidance: Sage expects that its existing cash, cash equivalents and marketable securities will fund operating expenses and capital expenditure requirements, based on its current operating plan, into the second quarter of 2018.
- The Society of Neuroscience Annual Meeting, San Diego, November 12-16
- The Stifel Healthcare Conference, New York, November 16
- The American Epilepsy Society Annual Meeting, Houston, December 2-6
- Sage 2016 R&D Day, Boston, December 13
|Sage Therapeutics, Inc. and Subsidiaries|
|Condensed Consolidated Balance Sheets|
|September 30, 2016||December 31, 2015|
|Cash and cash equivalents||$||320,078||$||186,753|
|Prepaid expenses and other current assets||3,418||1,738|
|Total current assets||434,688||188,491|
|Property and equipment and other long-term assets||1,613||525|
|Liabilities and Stockholders' Equity|
|Total current liabilities||22,330||15,307|
|Total stockholders' equity||413,737||173,695|
|Total liabilities and stockholders' equity||$||436,301||$||189,016|
|Sage Therapeutics, Inc. and Subsidiaries|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||29,075||17,478||78,752||48,981|
|General and administrative||8,989||6,604||25,033||17,057|
|Total operating expenses||38,064||24,082||103,785||66,038|
|Loss from operations||(38,064)||(24,082)||(103,785)||(66,038)|
|Interest income, net||275||53||717||115|
|Other expense, net||(7)||(6)||(18)||(10)|
|Net loss||$ (37,796)||$ (24,035)||$ (103,086)||$ (65,933)|
|Net loss per share - basic and diluted||$ (1.15)||$ (0.84)||$ (3.20)||$ (2.40)|
|Weighted-average shares outstanding - basic and diluted||32,975,897||28,737,743||32,218,204||27,430,275|